(332 days)
No
The summary describes a bone graft material and its composition, with no mention of AI or ML technology.
Yes
The devices are intended to be packed into bony voids or gaps of the skeletal system to aid in bone growth, which directly treats a physiological condition.
No
The device is a bone void filler intended to promote bone growth, not to diagnose a condition.
No
The device description clearly states it is derived from human allograft bone tissue and is a physical product (putty or gel) intended for surgical implantation. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to fill bony voids or gaps in the skeletal system (specifically the posterolateral spine). This is a therapeutic use, not a diagnostic one.
- Device Description: The device is a bone graft substitute made from human allograft bone tissue and a carrier. It is implanted into the body.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on the device's ability to promote bone growth (osteoconductive and osteoinductive potential) in animal models, which is relevant to its therapeutic function.
IVD devices are used outside the body to examine specimens from the body. This device is implanted inside the body for a therapeutic purpose.
N/A
Intended Use / Indications for Use
The SurFuse™ Gel, SurFuse™ Putty, ExFuse™ Gel, and ExFuse™ Putty products are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are intended to be gently packed into bony voids or gaps of the skeletal system (posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Product codes
MQV, MBP
Device Description
The SurFuse™ and ExFuse™ family of products are derived from human allograft bone tissue that is processed into a powder and demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a resorbable carrier, carboxymethylcellulose (CMC) and formulated into a putty or gel-like consistency. The ExFuse™ products also contain cancellous bone powder. The products are provided sterile for single patient use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (posterolateral spine)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The devices were tested successfully to fully characterize their osteoconductive ability to grow bone in the in vivo rabbit spinal model.
They also have been tested in vivo in the athymic (nude) rat muscle pouch model and were shown to have osteoinductive potential, in that new bone grew within the muscle tissue. The osteoinductive potential also was evaluated with a surrogate, in vitro BMP-2 ELISA, assay. Results from that assay were correlated with results from the same lots in which bone successfully formed in the athymic rat.
Each lot of the SurFuse™ and ExFuse™ devices will be evaluated for osteoinductive potential using the in vitro assay.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.
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Submitter:
Hans Biomed Corp.
SurFuse™ and ExFuse™
Traditional 510(k)
510(k) SUMMARY
| Submitter Name: | HansBiomed Corp. |
|---|---|
| Submitter Address: | 8 Floor SK Building Seongsu 1-ga |
| Seongdong-gu | |
| Seoul, 133-110 Korea | |
| Contact Person: | Ms. Lucy Choi |
| Phone Number: | 0082 2 466 2266 |
| Fax Number: | 0082 2 463 1554 |
| NOV 15 2012 | |
| Date Prepared: | December 19, 2011 |
| Device Trade | |
| Name: | SurFuse™ Gel, SurFuse™ Putty, |
| ExFuse™ Gel, ExFuse™ Putty | |
| Device Common | |
| Name: | Resorbable bone void filler, human bone graft material |
| Classification | |
| Number: | 21 CFR 888.3045 |
| Product Code and | MQV and MBP |
| Classification Name | Filler, bone void, calcium compound |
| Filler, bone void, Osteoinduction (w/o Human Growth Factor) | |
| Device Class | II |
| Predicate Devices: | K040419, DynaGraft II Gel and Putty, IsoTis OrthoBiologics, Inc. |
| K053319, Allomatrix® Cusotm Putty, Wright Medical | |
| Technology, Inc. | |
| Statement of | |
| Intended Use: | The SurFuse™ Gel, SurFuse™ Putty, ExFuse™ Gel, and |
| ExFuse™ Putty products are indicated for bony voids or gaps | |
| that are not intrinsic to the stability of the bony structure. They | |
| are intended to be gently packed into bony voids or gaps of the | |
| skeletal system (posterolateral spine). These defects may be | |
| surgically created osseous defects or osseous defects created | |
| from traumatic injury to the bone. | |
| Device Description: | The SurFuse™ and ExFuse™ family of products are derived |
| from human allograft bone tissue that is processed into a | |
| powder and demineralized using a hydrochloric acid process. | |
| The demineralized bone matrix (DBM) is combined with a | |
| resorbable carrier, carboxymethylcellulose (CMC) and | |
| formulated into a putty or gel-like consistency. The ExFuse™ | |
| products also contain cancellous bone powder. The products | |
| are provided sterile for single patient use. |
નં
1
SurFuse™ and ExFuse™ Traditional 510(k)
Safety:
The donor bone is obtained from AATB-certified tissue banks in the United States. The tissues are screened for the standard panel of infectious viruses. Further the manufacturing and sterilization processes have been validated to inactivate the HIV-1, Bovine Herpes Virus (BHV), Bovine Viral Diarrhea Virus (BVDV), Hepatitis A Virus (HAV) and Porcine Parvovirus (PPV).
Biocompatibility testing, according to ISO 10993, has been performed and the devices have been shown to be safe, nontoxic and biocompatible.
Performance:
The devices were tested successfully to fully characterize their osteoconductive ability to grow bone in the in vivo rabbit spinal model.
They also have been tested in vivo in the athymic (nude) rat muscle pouch model and were shown to have osteoinductive potential, in that new bone grew within the muscle tissue. The osteoinductive potential also was evaluated with a surrogate, in vitro BMP-2 ELISA, assay. Results from that assay were correlated with results from the same lots in which bone successfully formed in the athymic rat.
Each lot of the SurFuse™ and ExFuse™ devices will be evaluated for osteoinductive potential using the in vitro assay.
Osteoinduction assay results observed in surrogate assessments should not be interpreted to predict clinical performance in human subjects.
Comparison to the Predicate Devices:
These device families, with respect to material composition, device characteristics and intended use, are substantially equivalent to the two predicate device families.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter Dated: November 15, 2012
Hans Biomed Corporation % Trisler Consulting Ms. Patsy J. Trisler, JD, RAC Regulatory Consultant 5600 Wisconsin Avenue, #509 Chevy Chase, Maryland 20815
Re: K113728
Trade/Device Name: SurFuse" Gel and Putty, ExFuse™ Gel and Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV, MBP Dated: October 22, 2012 Received: October 25, 2012
Dear Ms. Trisler:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
3
Page 2 -- Ms. Patsy J. Trisler, JD, RAC
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Laurence D. Coyne
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SurFuse™ and ExFuse™ Traditional 510(k)
510(k) Number (if known):
Device Name:
SurFuse™ Gel and Putty ExFuse™ Gel and Putty
Indications for Use:
The SurFuse™ Gel, SurFuse™ Putty, ExFuse™ Gel, and ExFuse™ Putty products are indicated for bony voids or gaps that are not intrinsic to the stability of the bony . structure. They are intended to be gently packed into bony voids or gaps of the skeletal system (posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Samuel V. Gammon
(Division Sign-Off) Division of Orthopedic Devices 310(k) Number K113728
Section 4.0
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